New Repatha analyses show efficacy and safety across risk groups
Consistently reduced low-density lipoprotein cholesterol in patients across cardiovascular risk subgroups or with familial hypercholesterolemia.
Amgen has announced data presented at the European Society of Cardiology (ESC) Congress 2016 showing Repatha (evolocumab) consistently reduced low-density lipoprotein cholesterol (LDL-C) in patients across cardiovascular (CV) risk subgroups or with familial hypercholesterolemia (FH).
"These analyses continue to shape the clinical evidence for Repatha and help to advance our understanding of its potential to benefit patients," said Sean E. Harper, executive vice president of Research and Development at Amgen. "The data at ESC provide further insights into the impact of Repatha on multiple patient populations who are at higher cardiovascular risk and are in need of additional treatment options."
Researchers looking at the "Efficacy of evolocumab in patients across ESC/EAS CV risk subgroups," categorized a total of 2,532 patients from three, 12-week Phase III studies by the four ESC/European Atherosclerotic Society (EAS) risk criteria (very high, high, moderate and low). The analysis showed that treatment with Repatha 140 mg every 2 weeks or 420 mg monthly consistently reduced levels of LDL-C and other lipids from baseline to the mean of weeks 10 and 12 across all risk categories compared to placebo or ezetimibe controls. For example, among very high-risk patients, Repatha reduced LDL-C levels from baseline 65.2% more than placebo and 40.7% more than ezetimibe. The rates of overall adverse events were similar for the three groups, occurring in 43.1%, 50.5% and 40.8% of patients on Repatha, ezetimibe and placebo, respectively.
In another presentation, researchers looking at the "Long-term safety, tolerability and efficacy of evolocumab in patients with heterozygous familial hypercholesterolaemia," found that treatment with Repatha for 48 weeks resulted in persistent and marked LDL-C reductions in these patients. The analysis showed that Repatha plus standard of care (SoC) reduced LDL-C levels from baseline by 53.6% at 48 weeks (n=279), compared to a 2.1% increase for SoC alone. The pooled analysis included 440 patients with heterozygous familial hypercholesterolemia (HeFH) who completed Amgen's RUTHERFORD-1 (Phase II) or RUTHERFORD-2 (Phase III) trials and entered open-label extension trials (OSLER-1 or OSLER-2). Patients were randomized in the extension trials to receive SoC alone or Repatha plus SoC. Repatha was well tolerated in the extension studies with no new safety signals. The rates of overall adverse events were similar for the two groups, occurring in 80% of patients receiving Repatha and 67% of patients receiving SoC.
"These long-term data add to the growing body of evidence supporting Repatha's ability to meaningfully reduce LDL cholesterol levels in patients with familial hypercholesterolemia," said G. Kees Hovingh, Academisch Medisch Centrum, Vascular Medicine, Amsterdam, the Netherlands. "Familial hypercholesterolemia is an inherited condition that leads to high levels of LDL cholesterol from birth, and these high LDL cholesterol levels can result in increased risk for premature cardiovascular disease in patients with FH. This understanding is important for the HeFH patients in whom adequate control of their cholesterol levels with other currently approved lipid-lowering agents has been troublesome."
Additional data at the Congress included a Rapid Fire Abstract entitled, "Familial Hypercholesterolaemia Diagnosis: A Case of Missed Opportunity," which suggested that as few as 1 in 10 FH patients may be diagnosed. Patient-level data available in the Clinical Practice Research DataLink (CPRD), a UK-based general practice database, indicated a FH prevalence of 1.3 per 1,000 persons, which increased to 11.7 when missed diagnoses were counted.
Related News
-
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare. -
News Pfizer forges ahead with blood cancer therapy after approval from FDA
Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients. -
News Alzheimer's drug donanemab deemed effective in landmark clinical trial
Results from the TRAILBLAZER-ALZ 2 Randomised Clinical Trial into the use of donanemab to treat early symptoms of Alzheimer’s disease have been analysed.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance